1. Bundles of Care and Sepsis
Dr Raymond McKee
Consultant in Intensive Care Medicine and Anaesthesia
Craigavon Area Hospital
30th August 2013
2. Overview
• Brief history of “care bundles”
– Why are they used?
• What’s in a bundle?
• How do they work?
– And what is the evidence they do (or don’t)?
• Surviving Sepsis: Guidelines and bundles
3. • What I’m not going to do
– A line by line dissection of the SSC Guidelines
• You can do that yourself!
– Lists of bundles and what they contain
• …!
– Repeat much of what you’ve heard already
• Stop me if I do…
4. Why “bundles of care”?
• Definitions, in recent years, have added clarity
• Patients, however, do not readily fit into the
neat boxes as described
“There is no such thing as a typical patient
with sepsis; we should avoid ‘lumping
together’ all these patients”1
1 The Problem of Sepsis JL Vincent et al ICM 1994
5. Why “bundles of care”?
• While undoubtedly true…
– Previous practical experience was that there was
NO degree of consistency of approach
• Huge variation in individual and institutional practice
• Huge outcome variation
=NOT GOOD
6. A Brief History…
• American initiative
– Not entirely altruistic…
– IHI considered high-risk, high-cost interventions
• Radically different approach
– Considered systems approach to care delivery
– Also critically examined any/all assumptions made
in delivering that care
7. A Brief History…
• Using IHI approach
– Easiest areas to tackle are those with
• Significant potential problems
• Strong evidence base to direct change
• Also identified important basic aspects
– Multi-disciplinary teamworking
– Communication
8. A Brief History…
• 2 subject areas fitted these criteria
– Care of patients on ventilators
– Central line care
Already researched
Known individual interventions to improve outcome
• Widely accepted
• Previously considered individually
9. A Brief History…
• The difference was they combined the
interventions in a “bundle”
– Small group, to increase buy-in and adoption
– Initially to small group of ICUs (13 in US)
• A “bundle of care”…
11. • Primary aim was reduction of complications associated with
mechanical ventilation
• Contents straightforward
Initial reaction: “of course we do that”
• Required that, to achieve bundle compliance, all elements
must be enacted
12. Ventilated Care Bundle
• Before participation, units predicted c. 90%
compliance
– This was a little optimistic; even if 90% compliant
90% of the time, with 5 bundle elements, the
overall compliance is (0.9)5 = 60%
– In reality, initial recording showed these units to
have compliance 10-20%
13. Ventilated Care Bundle
• The poor initial results acted as a catalyst
– Individual units had hard evidence they were not
as good as they thought
– Direct challenge to assumed practice
– “Kick start” to allow systems change
14. Do they work?
• Yes…and no
– Ventilated bundles: those with >95% compliance
showed that VAP rates were reduced by c. 40%;
and sustained2
• Great; but why?? These were high-performing units,
which had already considered the individual elements
in the bundle, but without these results.
2 Resar et al (2005)
15. More Results
• Other studies have shown comparable
results345
– Interestingly, these studies didn’t follow all IHI
recommendations
– 1 study6 used only 2 IHI recommendations
• Sedation breaks; daily chlorhexidine
But with similar, sustained results
Why??
3Burger et al, Mayo Clin Proc 2006
4Youngquist et al JCJQPS 2007
5Bird et al Arch Surg 2010
6Rello et al VAP Care Contributors 2010
16. The Theory…
• Realisation that change is necessary
– First find out what you think you do; then
measure this against the “benchmark”
• Multi-disciplinary approach to design and
implementation
– Means more likely that all bases covered
• Makes ongoing commitment easier
17. The Theory…
• Small changes grouped together: this requires
a level of teamwork and co-operation which
results in high levels of sustained performance
– Not seen if working on individual items separately
18. Or…
• If implemented correctly, a bundle will
improve patient care by improving
collaborative teamwork
– This is what improves care, and therefore
outcomes
• This can happen pretty much independently
of the actual contents of the care bundle
34. Surviving Sepsis Bundle
• Initial resuscitation
– Cut down to minimum: lactate; fluid
• Sepsis screening
– Culture; antibiotics
• Ongoing care
– Vasopressors if non-fluid responsive
– Target interventions and reassess
35.
36. Surviving Sepsis Bundle
• The current Sepsis Care bundle from the
expert advisory group therefore:
– Relatively short
– Independent elements
– Defined timescale
– Largely descriptive (except fluids)
– Compliance…??
37. Sepsis Bundles: do they work?
• Plenty of evidence to show that implementing
a sepsis care bundle is associated with
improved outcome
– Gao7: prospective study. Age and severity
matched: Mortality 49% - 23% following
implementation
However…
7 Gao et al Crit Care 2005
38. • Gao7: study variables deconstructed.
– Compliance with all elements of bundle: 52%
• Simmonds8 :UK teaching hospital
– Retrospective look at 46 pts meeting severe sepsis
criteria
• Received Abx within 3hrs: 52%
• Appropriate fluid resus within 6hrs: 57%
• Time from diagnosis to admission to Critical Care: 12.9hrs
• No patient had all relevant bundle elements enacted within
specified time frame
7 Gao et al Crit Care 2005
8 Simmonds et al JICS 9:124-7
39. Sepsis bundles: do they work?
• Surprised??
– Not really9…
– No facility in ED/MAU in UK to allow all aspects of
6hr bundle to be reliably enacted
– HDU bed capacity often does not allow patients to
be admitted in a timely fashion
9 McNeill et al Clin Med 8:163-5
40. Problems
• Guidelines behind the bundles are not the
subject of unanimous, or even majority,
agreement
– Pretty much ignored in Australasia
– Lactate: generally agreed that, in isolation, not
especially useful
• Lactate clearance has more utility10
– Fluid: much discussion in literature over the
dangers of a blanket fluid requirement
• Over and significant under-resuscitation
10Nguyen et al Crit Care Med 2006
41. Problems
• Guidelines behind the bundles are not the
subject of unanimous, or even majority,
agreement
– Vasopressors: finally, the realisation that
dopamine is no use
– Quantitative resuscitation:
• CVP and ScvO2 endpoints from Rivers EGDT
• Significant discussion regarding generalizability of these
endpoints to a varied population of sepsis patients
44. Ongoing Discussion…
• Steroids remain a controversial topic
– And I think we’ll hear more about this
• Immunoglobulins
– Playing an increasing role in certain shock states in
specific aetiologies
• This needs further work; again, I think guidelines here
will change…
45. To finish…
• Back to the start:
– JL Vincent: one size most certainly does not fit all
• So why bother with guidelines and bundles?
– Complex subject matter
– Lack of overall agreement on treatments
– Inability to carry out many of the required actions
for a multitude of reasons
46. • Short answer: because they work; because
they have been shown to work, in terms of
improved outcome
– But for the reasons outlined at the start
• Improved multi-disciplinary care
• Better, more efficient team-working
• Realisation that the problem exists
47. • Care bundles are an excellent idea
– Should be our aim to ensure all our patients are
managed appropriately and aggressively
• Reduced organ failures
• Reduced mortality
• No care bundle for an area as diverse as sepsis
management, will ever be perfect
– Creating a set of broadly applicable interventions
to consider in all patients, all the time IS important
48. • A Bundle can
– Bring together these ideas
– Crystallise them into a small set of bullets
– Allow wide dissemination to ALL those caring for a
defined patient group
– Allow realisation that intervention early will
improve mortality
– Establish and reinforce application of best practice
Notas do Editor
When discussing SIRS,sepsis, septic shock, MOF, etc…definitions now relatively clear.
While both comments from JLV are very relevant, important to remember that 20yrs ago in practice, there was no degree of consistency of approach to care for these patients
The American approach (Institute for Healthcare Improvement) came from cost control issues: they began to look at procedures and processes which carried significant risk (and therefore expense, in USA, if they went wrong), and those which were expensive in their own right.What was different, was their approach: it was driven by those with non-medical background (the “managers”), who wanted to take in all aspects associated with an intervention, not just the medical/nursing ones.A systems approach to care delivery was a relatively new concept in medicine, but given the managerial/financial lead in US healthcare, it was a more easily understood concept.They also insisted on a completely blank canvas: there was to be no dogma, or preconceived assumptions blindly accepted.
Ventilators and CVCs already had research showing that there were interventions associated with decreasing risk: such as: ways of reducing GI ulceration; reducing DVT and PE risk in immobile patients; reducing time spent ventilated. For CVCs: good asepsis; proper consideration of insertion site; good post-procedure care; All easy to do; with evidence, and relatively non-controversial.
What IHI did was to bring a small number of these interventions together, in a “bundle”, and trialed their introduction in a small group of US ICUs.
Bundles were never designed to represent a comprehensive care package; rather highlight important aspects which should be carried out irrespective of other issues. All about increasing multi-disciplinary buy-in, while leaving a degree of latitude (by being descriptive rather than prescriptive) for individual unit bundles to reflect local needs.Importantly, the compliance needs to be looked at, and in a specific “all-or-none” way.
Important to bear in mind that the units chosen for the initial pilots were not “bad” or poorly performing; quite the opposite: they had been chosen because they were considered good to excellent, with a track record of excellence in care.These figures were, however, to prove vital when considering the process as a whole…
The SSG were introduced following the introduction of activated protein C onto the market, with a huge fanfare, but importantly significantly raising the profile of sepsis as an illness which killed many millions of people per year. The initial SSC was introduced with funding from Eli Lilly, who made aPC.The most recent iteration has a number of updates which reflect more up to date studies in the area.
This initial resuscitation is supposed to be carried out in the first 6 hours following diagnosis, and “should not be delayed pending ICU admission”.
Important points here: Early antibiotics; Daily reassessment to consider de-escalation, guided by PCT or other assays, if possible.Ultimate source control should be as rapid as possible; 12 hrs is suggested.
If not covered: Not for steroids if adequate fluid resus and pressors restore haemodynamic stability. (CORTICUS)
Blood: Hb 7-9 from TRICC.Immunoglobulins: currently not recommended in sepsis, however still considered relevant treatment in TSS due to staph and Group A Strep.
4 elements within 3 hours. A further 3 elements within 6 hours.